ISO 13485:2016 Lead Auditor Training Course

This course teaches the key principles and practices of effective quality management system audits in accordance with ISO 13485:2016 and ISO 19011, “Guidelines for auditing management systems”. Experienced instructors guide students through the entire audit process, from managing an audit programme to reporting on audit results. Participants will gain the knowledge and skills to plan, conduct, report and follow up a QMS audit that establishes conformity and enhances overall organizational performance. 

Who should attend?

  • Medical device quality professionals interested in conducting first-party, second-party, and/or third-party audits
  • Management representatives
  • Quality directors, managers, and engineers
  • Consultants

Do you already have a good knowledge of ISO 13485:2016?

If not, we highly recommend you take our ISO 13485:2016 Clause by Clause training course first as there are particular requirements you need to understand before you can be an auditor.

"We are proud to have the standard. It gives us enormous credibility with our potential customer base and with that credibility we give them confidence."

What will I learn?

On completion of this training, participants will be able to:

  • Gain the skills to plan, conduct, report and follow up an audit in accordance with ISO 19011
  • Identify the purpose and benefits of an ISO 13485:2016 QMS
  • Explain the role of an auditor in planning, conducting, reporting and following up an audit in accordance with ISO 19011 (and ISO 17021 where appropriate).

How will I benefit?

  • Identify the aims and benefits of an ISO 13485:2016 audit
  • Interpret ISO 13485:2016 requirements for audit application
  • Plan, conduct and follow-up auditing activities that add real value
  • Grasp the application of risk-based thinking, leadership and process management
  • Access the latest auditor techniques and identify appropriate use
  • Build stakeholder confidence by managing processes in line with the latest requirements
  • Understand the arrangements for BSI certification

What's included?

The residential and non-residential courses both include: 

  • You will gain 40 CPD points on completing the course
  • Course notes
  • Lunch 
  • Refreshments

The residential option also includes 4 nights accommodation and evening meals from the first day of the course.

Additional course options

  • Discover our ISO 13485 Qualifications - Our ISO 13485 auditor qualifications will give you a BSI Mark of Trust, reassuring your customers and suppliers that your skills have been validated. You can achieve Practitioner or Professional status by successfully completing courses, exams and demonstrating practical application. Find out more

  • In-house training - If you have a group of people to train an expert tutor can deliver training at your premises. Want to know more? 
    Request a quote for in-house training

 


COVID-19: Important information on classroom-based training courses

BSI is closely monitoring UK Government Advice regarding the safety of classroom-based training courses. We’ve been working with all our venues to ensure that COVID secure measures are in place and a member of our team has visited each venue to personally check things over. Enhanced cleaning procedures have been implemented, food and beverage offers adapted, and meeting room layouts have been modified to enable socially distanced events – with anti-bacterial gel and wipes readily available.

If you have any questions regarding your booking of a classroom-based training course, please contact training@bsigroup.com or call +44 345 086 9000.


Save on your learning journey with the BSI Training Academy*

With BSI training online, you can unlock discounts when booking your learning pathway, helping you shape your next few weeks, months or years of development – whilst saving in the process.

Make the most of your training budget by booking your next 2 or more courses with BSI before 31 March 2021 and you’ll save:

  • 15% off your next course

  • 20% off your second course

  • 25% off your third course

Contact our training team today to find out more and book your place. Call +44 345 086 9000 or email training@bsigroup.com.

*Terms and Conditions: Applies to all public BSI UK training courses, booked before 31 March 2021 and delivered within 12 months, via live online training only. Call our training team on +44 345 086 9000 or email training@bsigroup.com for more information.  Discounts applicable when booking 2 or more courses. Bookings must be made at the same time to qualify. Moves, changes and cancellations are not permitted. Payment required or invoice issued at the time of bookings. This offer does not apply to BSI re-sellers or Cybersecurity and BRCGS courses. This offer does not apply to BIM qualifications, where existing course packages are available. Offer is valid for new BSI UK training bookings only. Offer is not to be used in conjunction with any other offer. Offer subject to availability of training courses. Bookings are non-transferable. All other terms and conditions for training courses apply.